Alembic Pharmaceuticals Limited has secured final approval for its abbreviated new drug application (ANDA) for Paclitaxel Injection USP, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL) multiple-dose vials from the US Food & Drug Administration (FDA).
According to the Indian pharma company, this is the maiden product approval for oncology injection from its F-2 facility (Oncology Injectable) which recently underwent its first FDA inspection.
The approved product is a generic version of Taxol Injection, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL).
Paclitaxel Injection, USP is approved as subsequent therapy for treating advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP has the approval to be used in combination with cisplatin.
It is also indicated for the adjuvant treatment of node-positive breast cancer sequentially administered to standard doxorubicin containing combination chemotherapy.
According to IQVIA, Paclitaxel Injection USP has an estimated market size of $26 million for 12 months ending June 2022.
Alembic Pharmaceuticals has a cumulative total of 172 ANDA approvals from the FDA, which includes 148 final approvals and 24 tentative approvals.
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